Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3866 in participants with impaired renal function.
Key facts
- Study ID
- NCT03259087
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 42
- Starts
- 2017-09-01
- Expected to finish
- 2018-02-09
- Last updated by the study team
- 2019-04-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Females of non-childbearing potential. Male participants with female partner(s) of child-bearing potential agree to use a medically acceptable method of contraception during the study and for 90 days after dosing. If partner is pregnant, males agree to use a condom; if partner is of child-bearing potential, partner must use additional birth control
- Male participants agree not to donate sperm from the first dose until 90 days after dosing
- Adequate venous access
- Renal Impaired Participants
- Liver function tests (serum alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) and serum bilirubin (total and direct) within upper limit of normal
- Panels A, B, and C: no clinically significant change in renal status at least 1 month prior to dosing and not currently or previously been on hemodialysis
- Panel E only: ESRD maintained on stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing
- Healthy Participants
- Age within ± 15 years of the mean age of participants with impaired renal function to which the healthy participant is matched
- Medically healthy as per medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory safety tests
- Blood urea nitrogen, liver function tests (ALT, AST, alkaline phosphatase [ALP]), and serum bilirubin (total and direct) within upper limit of normal.
You may not qualify if…
- Mentally/legally incapacitated, or significant emotional problems or significant psychiatric disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, respiratory, genitourinary or major neurological abnormalities or diseases
- History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Clinically significant history of cancer
- Smoker and/or has used nicotine or nicotine-containing products within 3 months prior to screening
- Female participants of childbearing potential, pregnant, or lactating
- Positive results for urine or saliva drug screen and/or urine or breath alcohol screen at screening or check-in
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Consumes more than 3 glasses of alcoholic beverages within 6 months of screening
- Consumes excessive amounts of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
- Major surgery, donated or lost 1 unit of blood within 4 weeks prior to screening, or donated plasma within 7 days prior to dosing in Part 1 or first dose in Part 2
- Renal Impaired Participants
- Panels A, B, and C: Failed renal transplant or has had nephrectomy
- Panels A, B, and C: Rapidly fluctuating renal function, as determined by historical measurements; or demonstrated/suspected renal artery stenosis
- Panel E only: Has required frequent emergent HD (≥3) within a year prior to first dosing
- Healthy Participants
- Renal transplant or nephrectomy
Where it is running
- Clinical Pharmacology of Miami ( Site 0001) — Hialeah, Florida, United States
- Orlando Clinical Research Center ( Site 0002) — Orlando, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.